2024-519070-39-00RecruitingPhase 2
A phase II trial of an individualized treatment strategy for patients with metastatic non-clear cell renal carcinoma
Region Hovedstaden1 site in 1 country30 target enrollmentStarted: October 31, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR) + Time-to-treatment failure (TTF)
Study Overview
Brief Summary
To analyse the overall response rate, ORR (complete + partial response) in the total population based on RECIST (v1.1) criteria. To analyse time to treatment failure in the total population.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •1.Signed informed consent form must be obtained before any studyrelated procedures start.
- •The patient must be willing and able to follow the protocol.
- •Age ≥ 18 years
- •Histological biopsy-confirmed inoperable, locally advanced or metastatic non-cc RCC or 100% sarcomatoid tumour arising from the kidney found unsuited for surgery with a curative intent. Nephrectomy is not mandatory. a. If the primary disease was diagnosed more than 1 year ago, a new medium needle biopsy must be collected to confirm the diagnosis and tissue must be collected for DNA and RNA analyses. b. If a patient with inoperable relapse had a nephrectomy less than 1 year ago, and no tissue samples are stored in Dansk CancerBiobank, a new medium needle biopsy must be collected for DNA and RNA analyses. c. In cases where metastatic disease was confirmed by biopsy more than 1 year ago without initiated treatment, the patient is offered a new medium needle biopsy, but this is not mandatory for inclusion. d. If the patient had a nephrectomy with tissue stored in Dansk CancerBiobank and has been diagnosed with metastases within 1 year, the patient must be offered a new medium needle biopsy from a metastasis if the metastasis is easily accessible for biopsy, but a new biopsy is not mandatory for inclusion. e. A medium needle biopsy is mainly taken from a metastasis, but biopsy from a renal tumour is allowed. f. A biopsy may not be taken from bones as it cannot be used for molecular analysis. g. If the primary tumour is a proven clear cell RCC, but the biopsy from a metastasis shows non-cc RCC, the patient can be included in the study.
- •Sufficient tissue for DNA analyses, corresponding to 10 slides and RNA analyses corresponding to 1000 tumour cells.
- •Females with a negative pregnancy test or of non-childbearing potential (postmenopausal, hysterectomy or ovariectomy) and nonbreastfeeding.
- •Females of childbearing potential (<2 years after last menstrual period) and males must use effective contraception (pills, intrauterine device, diaphragm or condom with spermicide or sterilisation).
- •Measurable disease (according to RECIST 1.1 criteria)
- •Karnofsky Performance status ≥ 70% / ECOG Performance status 0-
- •See Appendix
- •Life expectancy more than 3 months.
- •At baseline, the laboratory values must be: Haematology: Leukocytes ≥ 3.0 x 10E9/L, thrombocytes ≥ 100 x 10E9/L, haemoglobin ≥ 6.2 mmol/l
- •Biochemistry: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), International Normalized Ratio (INR) ≤ 1.5, APTT ≤ 1.5 x ULN, AST, ALT ≤ 2.5 x ULN for patients without liver metastases, ≤ 5 x ULN for patients with liver metastases. eGFR > 30.
Exclusion Criteria
- •Previous systemic treatment for metastatic RCC (including neoadjuvant treatment).
- •Former adjuvant treatment with immune checkpoint inhibitors.
- •Major surgical procedure, open surgical biopsy or significant trauma within 28 days prior to initiation.
- •Serious non-healing wound, ulcer or bone fracture.
- •Auto-immune disease or other condition requiring systemic treatment with either corticosteroids (prednisolone > 10 mg/day or similar) or other immunosuppressive drugs
- •Metastases in the central nervous system (CNS). The patient must have an MRI scan (preferred) or CT scan of the brain (using contrast agent if possible) within 28 prior to initiation.
- •Seizures which cannot be managed with standard medical treatment.
- •If urine dipstick with protein ≥ 3+, urine must be collected over a period of 24 hours which must be < 3.5 grams/day. If degree 2 proteinuria, urine must be collected over a period of 24 hours prior to each prescription.
- •Other malignancy within 5 years (except for curatively treated basal cell carcinoma of the skin and/or cervix carcinoma in situ).
- •Uncontrolled hypertension (≥ 150 mm Hg systolic and/or ≥ 100 mm Hg diastolic) despite maximum antihypertensive medical treatment.
- •Clinically significant (i.e. active) cardiovascular disease, such as cerebrovascular conditions (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) congestive heart failure ≥ degree III or serious cardiac arrhythmia requiring medical treatment. Patients with well-managed AFib/AFL may be included.
- •Treatment using other investigational drugs or participation in other studies.
- •Previous or current other diseases, metabolic dysfunction, clinical findings on physical examination or clinical laboratory findings that give suspicion of a disease or condition that would contraindicate the use of an investigational drug or a patient with a high risk of treatment complications.
- •Patients where the investigator finds that patient compliance prevents safe completion of the treatment.
Outcomes
Primary Outcomes
Overall response rate (ORR) + Time-to-treatment failure (TTF)
Overall response rate (ORR) + Time-to-treatment failure (TTF)
Secondary Outcomes
- Progression free survival. Overall survival. Disease control rate. Duration of response. Patient-reported-outcome (PRO) usability. Description of patient-reported-outcome (PRO). Number of hospital admissions. Description of hospital admissions. Description of adverse events.
Investigators
Anne Kirstine Møller Darras
Scientific
Region Hovedstaden
Study Sites (1)
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